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G2Voice Broadcast #60 -What are your prescription and over the counter “drugs” doing to our body?

Sunday, Nov. 5, 2017 at 10 AM EST

Sunday is daylight savings end so now we are on EST

NOTE: Check out the medicine you take daily below and look into:• Contraindications• Warnings and Precautions• Adverse Reactions• Drug InteractionsThe Most Popular Drugs in the United States - Primary Use

NOTE: Let's go through one of these popular medicines and see for ourselves what it says. Do this with your drug and see if it resonates with you?EXAMPLE

The #1 Killer in the world is toxicity! The reason I say that is, if you look at the statistics you will see that Doctors and their pharmaceutical/medical prescribed protocols is added together in 2016, are the #1 killer of mankind. Why? They both are making the human body more toxic hence; death by doctors and pharmaceuticals! “Iatrogenics” means death by doctors and the protocols they have been taught to prescribe are the causes for death. To me, “Iatrogenics”, death by doctor, vaccines, prescriptions and over-the-counter “drugs” are the #1 killer and cause of “dis-ease” of the body in the world. All these drugs are TOXINS! Those are the real drugs. They are VERY toxic to the body and the sooner people we are helping get off their “meds”, the quicker they detox and the faster their body's HEAL! I saw my very healthy dad have a stroke from an “experimental” drug which left him as shell of a man until he died a few years later. He trusted the doctors and that was his downfall which led to his lack of “quality of life” before he died! We have been taught since very young from schools, news and even in the scripts from movies that doctors and the medical careers are honorable jobs and should be treated with respect. I have stopped believing that, as I have seen with my own eyes, people taking “meds” and following the advice of their doctors as their health deteriorates to even death. We are always told that we need to ask a doctor when we have any health issues. If not, then we are penalized, ridiculed and even fined by paying Medical insurance that we don't want or even need!

Note: Health care reform is not “insurance reform”, that is what the government is talking about. If it is health care reform, you'd see medical colleges changing their curriculum from a toxic drug-based Allopathic medicine to plant based or natural therapies which will NEVER happen due to the lack of profits! Until the “medical industry”, known as the FDA, AMA, CDC, NIH, DOJ and EPA cooperates, because of lack funding, then and ONLY then, we would see “healthcare” reform! But, I always promote “selfcare” as the VERY best way to maintain or restore health.

Here are two excellent documentaries that show the dangers of pharmaceutical drugs and the corruption of the FDA! Please educate yourself. It is your health that is at stake!

Arnold Seymour Relman, the former editor-in-chief of the New England Medical Journal, and professor of medicine at Harvard University, once stated: “The medical profession is being bought by the pharmaceutical industry, not only in terms of practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.” http://www.medicine.news/2016-09-23-doctor-tells-all-claims-prescription-drugs-are-killing-us.html

Dr. Peter Gotzsche, co-founder of the Cochrane Collaboration (the world’s most foremost body in assessing medical evidence), hopes to make clear this very problem. He is currently working to inform the world about the dangers associated with several pharmaceutical grade drugs. Based on his research, he estimates that 100,000 people in the United States alone die each year from the side-effects of correctly used prescription drugs, noting that “it’s remarkable that nobody raises an eyebrow when we kill so many of our own citizens with drugs.” He published a paper last year in the Lancet arguing that our use of antidepressants is causing more harm than good, and taking into consideration the recent leaks regarding antidepressant drugs, it seems he is correct.http://www.collective-evolution.com/2016/02/17/meet-the-doctor-who-says-prescription-drugs-are-killing-us-and-hes-not-the-only-one/

Note: Vioxx from Merck – 60,000 deaths!Botox just had a 680 million suit filed in California.

Every day, Americans are injured by side effects of dangerous drugs. For many, their only recourse is to file lawsuits against the companies that sell the products.The pharmaceutical industry makes sky-high profits that allow them to move quickly from one faulty drug to the next. From 2004 to 2008, Pfizer, one major pharmaceutical company, took in $245 billion. During that same time period, another company, Eli Lilly, made $36 billion from just one of its drugs (Zyprexa).Between 2004 and 2010, major drug companies paid out $7 billion in fines, penalties and lawsuits — just a drop in the bucket when compared with soaring profits. No one seems to care that every day, Americans are injured or killed by dangerous prescription drugs.Since 2000, the Food and Drug Administration (FDA) has approved an average of 24 drugs a year, including many that pose health risks and serious long-term side effects.

Drug companies help this happen when they conduct flawed or dishonest clinical trials by:Failing to report negative results to the FDA. Studying side effects for a short period of time. Studying a tiny group of people.

The FDA responds to adverse reactions to drugs in a variety of ways, such as meetings, reports, reviews, demands for more trials, letters to doctors, added warnings to labels, and requirements that patients enroll in special programs for drugs. FDA action, however, can take years — something patients may not have.Consumers who have been injured by a prescription drug often take action of their own by filing lawsuits against drug companies. These lawsuits can cover exorbitant medical costs, as well as pain and suffering. The most important role of the lawsuits is that they speak the drug companies’ language — money — and can teach them a lesson.Among the dangerous drugs out there are:Type 2 diabetes drugs Avandia and Actos. Antidepressants Paxil, Prozac, Effexor, Zoloft and Lexapro. Mood stabilizer Depakote. Birth control pills Yaz and Yasmin. Acne medication Accutane. Blood thinners Pradaxa and Xarelto Osteoporosis treatment Fosamax. GranuFlo and NaturaLyte, which are used in dialysis. Hair loss pill Propecia. These drugs come with side effects that range from birth defects and liver damage to suicidal behavior, blood clots, bladder cancer, Crohn’s disease, heart attacks, strokes, uncontrollable bleeding and heart failure.

Diabetes Drugs

ActosActos (pioglitazone) received FDA approval in 1999, and was celebrated as the next great type 2 diabetes drug. It has been prescribed to 10 million people around the world. Actos’ bright future began to grow dim in 2007, however, when the FDA added a black-box warning to the label, warning patients of the risk of heart failure.In 2011, the FDA added another warning to the Actos label — for bladder cancer. The label change came after Takeda Pharmaceuticals, which manufactures Actos, released study results showing that long-term use of Actos increases the risk of bladder cancer by 40 percent. France and Germany banned Actos in 2011. The FDA is waiting until final results from that study are released in 2013 to take any further action on Actos.While the FDA sits on its hands, a new study published in the British Medical Journal shows long-term use of Actos increases the risk of bladder cancer by 83 percent. Thousands of patients have filed lawsuits after going through multiple surgeries, radiation and chemotherapy — all thanks to the would-be miracle drug Actos.

Are you suffering from injuries related to a prescription drug or medical device?

Avandia

Avandia, another type 2 diabetes drug, also launched in 1999, but was later implicated in heart attacks. The FDA estimates that Avandia caused 83,000 heart attacks from 1999 to 2007, the year in which the FDA added a black-box warning to the drug. In September 2010, the FDA significantly restricted use of Avandia, allowing access only to a select group of doctors and patients.GlaxoSmithKline has settled at least 35,000 Avandia lawsuits, paying out $3 billion in late 2011 to settle cases involving several of its drugs as well as a government investigation. The two-year investigation by the U.S. Senate Finance Committee revealed that the drug company knew of the heart risks associated with Avandia for a long time and tried to hide concerns about the drug.

Antidepressants

PaxilIn 1992, SmithKline Beecham — which would later become GlaxoSmithKline — launched Paxil (Paroxetine), which is a selective serotonin reuptake inhibitor (SSRI). Like other antidepressants, Paxil carries a black-box warning that it can increase suicidality in children, adolescents and young adults.FDA reported in 2006 that 11 suicide attempts had occurred in patients given Paxil in trials. Based on the allegation that GlaxoSmithKline misled consumers about Paxil’s safety — including increasing suicidal behavior — a $64 million class-action suit was settled in 2007.One FDA study shows that pregnant women who take Paxil during the first trimester have double the risk of having a baby with a heart defect, compared to other women. GlaxoSmithKline has spent almost $1 billion to settle birth-defect litigation.

Pro zac

Pro zac (fluoxetine) is an antidepressant made by Eli Lilly that hit the market in 1987. Pro zac is an SSRI that is used for depression, obsessive compulsive disorder (OCD), bulimia nervosa and panic disorder.This medicine that has been prescribed to over 50 million people worldwide may cause serotonin syndrome and increases the risk of suicidal thinking and violent behavior.In 1989, Pro zac made the news as one man, Joseph Wesbecker, wounded 12 people and killed eight, before killing himself. Just weeks before the shooting, Wesbecker had started taking Pro zac. The victims’ families sued Eli Lilly and lost. In 2011, a 16-year-old boy received a three-year sentence after stabbing one of his friends. His doctor attributed his actions to a Pro zac-induced mood disorder.More than 150 lawsuits have been filed faulting Eli Lilly for not properly testing Pro zac to show that it may make users aggressive and suicidal. Eli Lilly is also facing lawsuits over birth defects that resulted from a woman’s use of Pro zac during pregnancy.In 2006, the FDA added labeling to all SSRIs warning of the increased risk of pulmonary hypertension in the newborn (PPHN), which can be fatal.

Effexor

Approved in 1993, Effexor (venlafaxine) is manufactured by Wyeth — which was later purchased by Pfizer — to treat depression, generalized anxiety disorder, social anxiety disorder and panic disorder. In 2005, sales of Effexor totaled $3.5 billion.In 2003, Wyeth warned health care professionals that in children ages 6 to 17 Effexor was not shown to be effective or safe, causing hostility and suicidal events. The U.K. General Practice Research Database was used in 2007 to compare antidepressants Celexa (citalopram), Prozac (fluoxetine), dothiepin and Effexor. The study showed that Effexor carries the highest risk of suicidality.Effexor and all antidepressants carry the FDA’s black-box warning about the risk of suicide during the early stages of treatment, especially in kids. Effexor use during pregnancy can cause serious birth defects, and many parents have sued Pfizer after their baby has suffered.

Zoloft

Zoloft (sertraline) is an antidepressant created by Pfizer and approved by the FDA in 1999. By 2011, nearly 100 million people had taken Zoloft. Mainly used to treat major depressive disorder, Zoloft is part of the SSRI drug class. SSRIs come with a risk of suicidality and violent behavior, especially in children and adolescents.Using Zoloft while pregnant can lead to birth defects, including persistent pulmonary hypertension in infants (PPHN), which can be fatal. In May 2012, more than 60 Lexapro (escitalopram) were filed on behalf of babies born with birth defects.

Lexapro

Approved by the FDA in 2002 to treat depression and anxiety, Lexapro (escitalopram) is a popular SSRI but is associated with birth defects. The drug, made by Forest Laboratories, had sales topping $355 million in 2011.Dozens of lawsuits have been filed after women took Lexapro and gave birth to children with birth defects. Birth defects resulting from Lexapro include persistent pulmonary hypertension of the newborn (PPHN), limb defects, spina bifida, cranial defects and neural tube defects.

Depakote

Depakote (divalproex sodium) is an anticonvulsant and is used to treat mood disorders, seizures and migraines. It was approved for its first indications by the FDA in 1983. The drug later was illegally marketed for unapproved uses, such as for youths with bipolar or seniors with dementia. As a result, Abbott Laboratories, the drug’s manufacturer, was required to pay $700 million in criminal penalties.Many women have filed lawsuits against Abbott Laboratories, after Depakote led to birth defects such as developmental delays, spina bifida, cleft palate and bodily malformations. A 2006 study showed that 20 percent of women taking the medication while pregnant gave birth to children with birth defects, and as a result the FDA gave the medication a black-box warning concerning potential birth defects.

Hormone Drugs

Testosterone

There are a number of testosterone replacement drugs currently on the market. The most popular and most prescribed drug in the U.S. is AngroGel (testosterone gel) manufactured by Abbott Laboratories’ subsidiary, AbbVie.The National Institutes of Health (NIH) funded one of the most recent studies published in PLOS ONE. The study was based on the records of 55,000 men who were prescribed testosterone in the U.S. Researchers found the risk of heart attacks doubled for men who had used testosterone during the first three months. There have been other studies that also show an increased cardiovascular risk.Based on these findings, watchdog group, Public Citizen, petitioned the FDA to add a black box warning to all testosterone drugs. Dr. Sidney Wolf wrote in an article published in BMJ on February 27, 2014 that 1 in 167 men over aged 65 will have a heart attack because of testosterone drugs. For men under 65 with preexisting heart conditions, that risk jumps to 1 in 100.Men who suffered heart attacks and strokes are already filing lawsuits against testosterone replacement drug makers.

Birth Control Pills

Yaz and Yasmin

Released in the United States in 2006, Yaz (drospirenone/ethinyl estradiol) is a birth control pill manufactured by Bayer. Yaz is a sister drug to Yasmin, which was approved in 2001. Both medications contain drospirenone/ethinyl estradiol, so they carry the same risk.From 2008 to 2009, Yaz was the top-selling birth control pill in the United States. In April 2012, Yaz continued in popularity as the fourth best-selling oral contraceptive. Yet several studies show that Yaz puts women at an increased risk for blood clots. Blood clots can contribute to deep vein thrombosis (DVTs), pulmonary embolism (PE), stroke or heart attack.On April 10, 2012, the FDA required Yaz to include a warning that drospirenone-containing pills increase the risk of blood clots by threefold. Also, a former FDA commissioner, David Kessler, filed an affidavit, claiming that Bayer withheld early reports of blood clots from the FDA in 2004.A multidistrict litigation (MDL) has been set up in Illinois to handle the 10,000-plus lawsuits over Yaz and Yasmin side effects.

Acne Medication

AccutaneApproved by the FDA in May 1982, Accutane (isotretinoin) is an oral medication from Roche that was once available for treating acne. Prescribed to more than 13 million patients, many users experienced cured acne after four to five months of treatment.Serious side effects from Accutane include inflammatory bowel disease, ulcerative colitis, Crohn’s disease, suicidal thoughts, birth defects, liver damage and gastrointestinal disorders. The Adverse Event Reporting System (AERS), a computer database of post-marketing adverse side effects, includes around 23,000 Accutane reports from 1982-2002, covering everything from alopecia (hair loss) and depression, to headache, dry skin and induced abortion.As of 2002, 172 babies had been born with a congenital defect or anomaly after the mother had taken Accutane. Through 2002, there was a cumulative total of 173 suicides in association with Accutane.The FDA met with Roche, the manufacturer of Accutane, in 2000 to set up a program to ensure that no woman took Accutane during pregnancy and that no pregnancies would occur while a woman was taking Accutane. The SMART (System to Manage Accutane Related Teratogenicity) program was designed to minimize the risk of birth defects by requiring a qualification sticker on prescriptions, consent forms, an information guide, a patient video, a guide for those who prescribe drugs and pharmacists and carton instructions.Warnings concerning severe stomach pain, diarrhea and rectal bleeding were hidden in 3,000 words of possible side effects, and in 2005 Kamie Kendall won $10.5 million in damages after having her colon and rectum removed.Andrew McCarrell won $25 million after having his colon removed in 2007. In 2009, Roche Pharmaceuticals responded to multiple personal injury lawsuits by removing Accutane from the market. But the legal settlements didn’t end there. In 2012, Gillian Gaghan was awarded $2 million for injuries related to inflammatory bowel disease after using Accutane for six months.

Cholesterol Drugs

CrestorCrestor (rosuvastatin), made by AstraZeneca, was approved in August 2003. It is known to lower bad cholesterol up to 52 percent. Global sales reached $6.6 billion in 2011.Crestor belongs to a class of drugs known as statins. Crestor can cause rhabdomyolysis (muscle tissue damage), kidney (renal) failure and chronic or abnormal bleeding.The FDA has written letters to AstraZeneca demanding it stop running commercials that exaggerate the drug’s benefits and downplay its dangers. In 2005, the FDA added a warning to the drug that all patients who use high doses of Crestor — 40 mg a day — are at an increased the risk of developing life-threatening muscle damage.Sydney Wolfe from the Public Citizens Health Research Group — a nonprofit advocacy organization that represents consumer interests in Congress — said that in two years Crestor was linked to 117 cases of rhabdomyolysis and 41 cases of kidney failure, 11 of which resulted in death.

Blood Thinners

Pradaxa

Millions of Americans take blood thinners to reduce the risk of stroke caused by atrial fibrillation (irregular heartbeat). For decades, patients had limited options for blood thinners with most taking warfarin, a medication that requires diet changes and regular blood tests. All of that changed in October 2010, when the FDA approved Boehringer Ingelheim’s Pradaxa (dabigatran), a blood thinner that does not require the same maintenance as warfarin. Within two years, more than 3.7 million U.S. patients had filled Pradaxa prescriptions.All blood thinners make patients more susceptible to bleeding accidents, however, with Pradaxa there is no antidote to stop bleeding, which can lead to disabling or fatal injuries. Hundreds of bleeding accidents associated with Pradaxa have been reported, and 542 deaths were reported in 2011.Studies of Pradaxa also show an increased risk of heart attack and heart disease compared with warfarin. Nearly 200 people have filed Pradaxa lawsuits, most of which are consolidated in a multidistrict litigation (MDL) in Illinois.

Xarelto

One of the newest blood thinners is Xarelto (rivaroxaban), approved by the FDA in July 2011. Xarelto is approved for use after knee and hip replacement surgery to reduce the risk of blood clots. In November 2011, the drug’s indications were expanded to include atrial fibrillation (AF).There is no bleeding antidote for Xarelto, which means users of the drug can experience dangerous, uncontrollable bleeding events. Additionally, since the drug was fast-tracked, unknown side effects may also be putting patients at risk.

Osteoporosis Treatment

Fosamax

The FDA approved Fosamax (alendronate sodium), made by Merck, in 1995 to treat osteoporosis in postmenopausal women. It is estimated that millions worldwide have used the drug for osteoporosis and other indications, including Paget’s disease.Some people taking Fosamax have suffered from injuries such as ONJ, or jaw death, joint and muscle pain, atrial fibrillation, and inflammation and ulcers of the esophagus. Nearly 1,000 people have filed lawsuits against Merck after experiencing severe side effects.

Pain Medication

Vioxx

Initially approved for acute pain such as rheumatoid arthritis in adults or menstrual related symptoms, Vioxx (rofecoxib) was available from 1999 to 2004. Vioxx is a part of a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs, and functions like ibuprofen. Merck manufactured the drug which reached sales of $2.5 billion in 2003.Multiple studies revealed that this drug meant to assist patients was actually increasing the risk of heart attack. September 2004 Merck voluntarily withdrew the drug from the market. Over 60,000 people have filed claims against Merck after Vioxx use led to heart attacks, strokes and other injuries.The company set up a $4.85 billion dollar fund to assist in resolving consumer claims. Additionally, Merck pleaded guilty to charges based on illegal marketing and agreed to pay fines of $950 million.

Gastrointestinal Drugs

Reglan

Reglan (metoclopramide) was approved by the FDA in 1980 and is used to treat migraines, heart burn, acid reflux, nausea, vomiting and gastroparesis, a digestive condition. In 2011, around 1 million people filled prescriptions of Reglan. That same year the Institute for Safe Medication Practices released a report that 1,180 cases of Tardive Dyskinesia resulted from Reglan use.Tardive Dyskinesia (TD) occurs as a side effect of certain medications and is a neurological disorder causing uncontrollable rapid movements of the face and the body. Severe cases can inhibit talking, walking and eating. Because of this, over 5,000 people have filed lawsuits against manufacturers of metoclopramide.

Dialysis Treatment

GranuFlo and NaturaLyte

Many people with acute or chronic kidney failure receive dialysis treatment with GranuFlo and NaturaLyte. Fresenius Medical Care (FMC), the world’s leading provider of kidney dialysis services and products, manufactures these two products. They were approved in 2003 to assist in dialysis treatment. The products are now used by around half of dialysis patients.Because dialysis machines were not properly calibrated, patients have suffered from excessive amounts of acid in the blood, which can lead to organ damage, heart arrhythmia, heart attack, coma and death. In 2012, these two products briefly were recalled to clarify dosing instructions. FMC now faces mounting lawsuits, after more than 900 patients suffered cardiac arrest after using their products.

Hair Loss Pill

Propecia and Proscar

Men struggling with male-pattern baldness or enlarged prostate may take Propecia or Proscar, which both include finasteride and are manufactured by Merck. The FDA approved Proscar in 1992 and Propecia in 1997.The FDA’s adverse event database received hundreds of reports of erec tile dysfunction associated with use of finasteride. Even after discontinuing use of the drug, patients may experience side effects. In April 2011, the FDA required updates to the drug label informing users that libido disorders, ejaculation disorders and orgasm disorders can occur during and after use of finasteride. The label also includes a warning concerning increased risk of high-grade prostate cancer.The reckless behavior of the drug companies shows no signs of changing. Negative clinical trials are never reported or overlooked, and the FDA buys in. Doctors write millions of prescriptions that may be damaging the health of innocent patients. Only by holding companies accountable in court for threatening their very lives, can patients help prevent others from suffering from the same faulty drugs.

Before the advent of “Big Pharma” early in the 20th century, these statistics just did not exist but now we have to deal with so many needless deaths from toxins that are entering the body through prescribed medications. One thing people can do is to make a more informed decision in what they allow to be put in their bodies. Every pharmaceutical company that has an “approved” drug on the world market has to disclose a list of information good and bad about each drug it produces in publication called, “package insert”. Being “approved” doesn’t mean it is safe or non-toxic in your body as you will see from their own publications!

What is in the Package Insert?

The package insert is a very detailed publication and filled with information provided by the drug manufacturer and approved by the US Food and Drug Administration (FDA). Each country or region has its own agency that regulates drugs and provides the information that consumers receive with their prescriptions. In India, it is the Central Drugs Standard Control Organization (CDSCO), which is commonly referred to as the Drugs Controller General (DCG). In Europe, it is the European Medicines Agency (EMA), where the package insert is known as the patient information leaflet (PIL).

Package inserts (also known as Prescribing Information or drug labels) are available for all prescription medications approved by the FDA. Similar information is available for nonprescription medicines and for some herbal medicines and dietary supplements as well.

The package insert can usually be found online on the drug manufacturer's web site and also available in a reference book called the Physicians' Desk Reference (PDR).

The information in a package insert is in technical language. It is usually very long and can be difficult to understand. It is a good idea to look through it, because it lists important information about the drug. The package insert follows a standard format for every drug. After some identifying information such as the drug's brand name, generic name, and initial year of FDA approval, the following sections appear:

A woman here in Colombia whom we are giving “sacramental guidance” has been telling me about the symptoms she has been having the past few years from certain drugs. She is taking a drug called, “atenolol”. Below, is a list of the “Adverse Reactions” in the package insert from the Drug company.

The woman we are guiding with our health sacraments decided to stop taking this medication which she had been taking for years. Her doctor had never shown her this information or told her it existed! It is not a good business practice to show how dangerous and toxic the product you are trying to sell to a patient is before they begin to take it, right? I’m being facetious in case you didn’t notice. They, (the drug company), doesn’t want you to know this information, because you probably would not take the drug.

Many of the symptoms that the drug itself was causing her are disappearing after a week! Also, she has begun with the Starting Procedure and working her way up to Protocol 2000 while she is with us for a month. This will detox any residual amount of this drug that has accumulated in the body over the years as well as pathogens to “restore her to health”.

Below are the top 25 Prescribed drugs in the U.S. See if what you are being prescribed to take is on the list. If so, read the information in the package insert. I included a link. YOU decide if the doctor that prescribe it for you made the right choice for you!

I will walk you thru the high points of how the drug companies “package” inserts read:

Below is a link to the package insert from the Drug company that produced the “drug” to the top 25th most popular drugs in the U.S. CHECK IT OUT FOR YOURSELF!! I have made it easy for you to do that. Just click on the link of the drug you are taking and read what the drug companies say themselves about the drug they produce. You decide if you should be taking anyone of these drugs. It is not the doctor’s responsibility to check out this drug, but yours! You are the one ingesting it not the doctor. You have to dig to get to the sections: • Contraindications• Warnings and Precautions• Adverse Reactions• Drug InteractionsThe Most Popular Drugs in the United States - Primary UseNOTE: Let's go thru on of these popular meds and see for ourelves what it says. Do this with your drug and see if it resonates with you?1. Coumadin (Warfarin sodium) - http://medlibrary.org/lib/rx/meds/coumadin-3/

COUMADIN can cause fetal harm when administered to a pregnant woman. While COUMADIN is contraindicated during pregnancy, the potential benefits of using COUMADIN may outweigh the risks for pregnant women with mechanical heart valves at high risk of thromboembolism

CONTRAINDICATIONS

COUMADIN is contraindicated in:

Pregnancy COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)]. COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If COUMADIN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].COUMADIN is contraindicated in patients with:• Hemorrhagic tendencies or blood dyscrasias • Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see Warnings and Precautions (5.6)] • Bleeding tendencies associated with:• Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract• Central nervous system hemorrhage• Cerebral aneurysms, dissecting aorta• Pericarditis and pericardial effusions• Bacterial endocarditis• Threatened abortion, eclampsia, and preeclampsia • Unsupervised patients with conditions associated with potential high level of non-compliance • Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding • Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [see Adverse Reactions (6)] • Major regional or lumbar block anesthesia • Malignant hypertension

5 WARNINGS AND PRECAUTIONS5.1 HemorrhageCOUMADIN can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors [see Clinical Pharmacology (12.5)] , certain concomitant drugs [see Drug Interactions (7)] , and long duration of warfarin therapy.

Perform regular monitoring of INR in all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shortest duration of therapy appropriate for the clinical condition. However, maintenance of INR in the therapeutic range does not eliminate the risk of bleeding.

Drugs, dietary changes, and other factors affect INR levels achieved with COUMADIN therapy. Perform more frequent INR monitoring when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs [see Drug Interactions (7)].Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17)].

5.2 Tissue Necrosis

Necrosis and/or gangrene of skin and other tissues is an uncommon but serious risk (<0.1%). Necrosis may be associated with local thrombosis and usually appears within a few days of the start of COUMADIN therapy. In severe cases of necrosis, treatment through debridement or amputation of the affected tissue, limb, breast, or penis has been reported.Careful clinical evaluation is required to determine whether necrosis is caused by an underlying disease. Although various treatments have been attempted, no treatment for necrosis has been considered uniformly effective. Discontinue COUMADIN therapy if necrosis occurs. Consider alternative drugs if continued anticoagulation therapy is necessary.

5.3 Systemic Atheroemboli and Cholesterol Microemboli

Anticoagulation therapy with COUMADIN may enhance the release of atheromatous plaque emboli. Systemic atheroemboli and cholesterol microemboli can present with a variety of signs and symptoms depending on the site of embolization. The most commonly involved visceral organs are the kidneys followed by the pancreas, spleen, and liver. Some cases have progressed to necrosis or death. A distinct syndrome resulting from microemboli to the feet is known as “purple toes syndrome.” Discontinue COUMADIN therapy if such phenomena are observed. Consider alternative drugs if continued anticoagulation therapy is necessary.

5.4 Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS

Do not use COUMADIN as initial therapy in patients with heparin-induced thrombocytopenia (HIT) and with heparin-induced thrombocytopenia with thrombosis syndrome (HITTS). Cases of limb ischemia, necrosis, and gangrene have occurred in patients with HIT and HITTS when heparin treatment was discontinued and warfarin therapy was started or continued. In some patients, sequelae have included amputation of the involved area and/or death. Treatment with COUMADIN may be considered after the platelet count has normalized.

5.5 Use in Pregnant Women with Mechanical Heart Valves

COUMADIN can cause fetal harm when administered to a pregnant woman. While COUMADIN is contraindicated during pregnancy, the potential benefits of using COUMADIN may outweigh the risks for pregnant women with mechanical heart valves at high risk of thromboembolism. In those individual situations, the decision to initiate or continue COUMADIN should be reviewed with the patient, taking into consideration the specific risks and benefits pertaining to the individual patient’s medical situation, as well as the most current medical guidelines. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].5.6 Other Clinical Settings with Increased Risks

In the following clinical settings, the risks of COUMADIN therapy may be increased:• Moderate to severe hepatic impairment • Infectious diseases or disturbances of intestinal flora (e.g., sprue, antibiotic therapy) • Use of an indwelling catheter • Severe to moderate hypertension • Deficiency in protein C-mediated anticoagulant response: COUMADIN reduces the synthesis of the naturally occurring anticoagulants, protein C and protein S. Hereditary or acquired deficiencies of protein C or its cofactor, protein S, have been associated with tissue necrosis following warfarin administration. Concomitant anticoagulation therapy with heparin for 5 to 7 days during initiation of therapy with COUMADIN may minimize the incidence of tissue necrosis in these patients. • Eye surgery: In cataract surgery, COUMADIN use was associated with a significant increase in minor complications of sharp needle and local anesthesia block but not associated with potentially sight-threatening operative hemorrhagic complications. As COUMADIN cessation or reduction may lead to serious thromboembolic complications, the decision to discontinue COUMADIN before a relatively less invasive and complex eye surgery, such as lens surgery, should be based upon the risks of anticoagulant therapy weighed against the benefits. • Polycythemia vera • Vasculitis • Diabetes mellitus

Drugs may interact with COUMADIN through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with COUMADIN are synergism (impaired hemostasis, reduced clotting factor synthesis), competitive antagonism (vitamin K), and alteration of the physiologic control loop for vitamin K metabolism (hereditary resistance). Pharmacokinetic mechanisms for drug interactions with COUMADIN are mainly enzyme induction, enzyme inhibition, and reduced plasma protein binding. It is important to note that some drugs may interact by more than one mechanism.More frequent INR monitoring should be performed when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs, including drugs intended for short-term use (e.g., antibiotics, antifungals, corticosteroids) [see Boxed Warning].Consult the labeling of all concurrently used drugs to obtain further information about interactions with COUMADIN or adverse reactions pertaining to bleeding.

7.1 CYP450 Interactions

CYP450 isozymes involved in the metabolism of warfarin include CYP2C9, 2C19, 2C8, 2C18, 1A2, and 3A4. The more potent warfarin S -enantiomer is metabolized by CYP2C9 while the R -enantiomer is metabolized by CYP1A2 and 3A4.• Inhibitors of CYP2C9, 1A2, and/or 3A4 have the potential to increase the effect (increase INR) of warfarin by increasing the exposure of warfarin. • Inducers of CYP2C9, 1A2, and/or 3A4 have the potential to decrease the effect (decrease INR) of warfarin by decreasing the exposure of warfarin. Examples of inhibitors and inducers of CYP2C9, 1A2, and 3A4 are below in Table 2; however, this list should not be considered all-inclusive. Consult the labeling of all concurrently used drugs to obtain further information about CYP450 interaction potential. The CYP450 inhibition and induction potential should be considered when starting, stopping, or changing dose of concomitant medications. Closely monitor INR if a concomitant drug is a CYP2C9, 1A2, and/or 3A4 inhibitor or inducer.

Examples of drugs known to increase the risk of bleeding are presented in Table 3. Because bleeding risk is increased when these drugs are used concomitantly with warfarin, closely monitor patients receiving any such drug with warfarin.

There have been reports of changes in INR in patients taking warfarin and antibiotics or antifungals, but clinical pharmacokinetic studies have not shown consistent effects of these agents on plasma concentrations of warfarin.Closely monitor INR when starting or stopping any antibiotic or antifungal in patients taking warfarin.

7.4 Botanical (Herbal) Products and Foods

More frequent INR monitoring should be performed when starting or stopping botanicals.Few adequate, well-controlled studies evaluating the potential for metabolic and/or pharmacologic interactions between botanicals and COUMADIN exist. Due to a lack of manufacturing standardization with botanical medicinal preparations, the amount of active ingredients may vary. This could further confound the ability to assess potential interactions and effects on anticoagulation.Some botanicals may cause bleeding events when taken alone (e.g., garlic and Ginkgo biloba) and may have anticoagulant, antiplatelet, and/or fibrinolytic properties. These effects would be expected to be additive to the anticoagulant effects of COUMADIN. Conversely, some botanicals may decrease the effects of COUMADIN (e.g., co-enzyme Q10 , St. John’s wort, ginseng). Some botanicals and foods can interact with COUMADIN through CYP450 interactions (e.g., echinacea, grapefruit juice, ginkgo, goldenseal, St. John’s wort).The amount of vitamin K in food may affect therapy with COUMADIN. Advise patients taking COUMADIN to eat a normal, balanced diet maintaining a consistent amount of vitamin K. Patients taking COUMADIN should avoid drastic changes in dietary habits, such as eating large amounts of green leafy vegetables.

NOTE: (NaturalNews) Aluminum Lake food coloring, used to heavily coat liquid medicines for children, contains dangerous amounts of aluminum and harmful synthetic petrochemicals. These "petrochemicals" are carcinogens containing petroleum, antifreeze and ammonia, which cause a long list of adverse reactions. Aluminum poisoning can lead to short and long term central nervous system (CNS) damage, such as memory impairments, autism, epilepsy, mental retardation, and dementia.

• Blue #1: Research shows it causes kidney tumors in mice.• Blue #2: Research shows even higher incidence of tumors, specifically gliomas in male rates (a type of tumor that starts in the brain or spine).• Red #2: Toxic to rodents, even at modest levels, and causes tumors of the bladder.• Red #3: FDA recognized it in 1990 as a cause of thyroid cancer in animals. It was banned in cosmetics, but still allowed in food and medicine.• Red #40: Most popular dye of all. Debilitates the immune-system in mice. Allergic reactions common.• Green #3: Causes bladder and testes tumors.• Yellow #5: Affects behavior and induces severe hypersensitivity reactions.• Yellow #6: Causes adrenal tumors in animals.

There were approximately four times as many major bleeding episodes in the two groups receiving warfarin than in the group receiving aspirin alone. Major bleeding episodes were not more frequent among patients receiving aspirin plus warfarin than among those receiving warfarin alone, but the incidence of minor bleeding episodes was higher in the combined therapy group.

Some foods and beverages can interact with COUMADIN and affect your treatment and dose.

• Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of COUMADIN. • Always tell all of your healthcare providers that you take COUMADIN. • Wear or carry information that you take COUMADIN.

NOTE: You will notice that there are different package inserts from different drug companies producing the same drug so check out the company package insert of the drug you are taking and compare to the other companies to see if they agree.I have written this newsletter so people who are considering taking a certain drug can make an “informed” decision. You will notice that the drug companies tell you to ask your doctor if a certain drug is “good” for you. That would be like asking a used car salesman if this car is good for me. 99% of the time he will say, yes of course it is because he wants to sell you the car. He makes money off the car! I believe that the person being asked or told to take a certain drug, should do his or her “due diligence” and see what the drug companies say about the drug they are producing. They are telling the world what drugs they are making and what results they are seeing from the people taking them. You need to listen to what they are putting in print! Now, if you decide that a certain drug being prescribed for you is “not good” for your health then you should have every right to deny taking it! The Genesis II Church of Health and Healing has sacraments that can protect our “temple” the body, from 99% of the things that can hurt it, i.e. toxins and pathogens. Each one of us personally needs to take responsibility for what enters our temples. I hope everyone will research what has been written to warn all of us about the dangers of many pharmaceutical products whether they are in the form of pills, vaccines, intravenously or any other manner of entering the body!

Conclusion: Next week: G2Voice Broadcast #61: What is “Gastritis” and how to CURE it!

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